NEUROTECHNOLOGY RESEARCH, DEVELOPMENT, AND ENHANCEMENT
RELEASE DATE: October 08, 2003
PA NUMBER: PA-04-006
March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. The R01 portion of this announcement has been
replaced by (PA-06-279) and will continue to be accepted using paper PHS 398
applications. A replacement R21 (PA-06-278) funding opportunity announcement has been
issued for the submission date of June 1, 2006 and submission dates
for AIDS and non-AIDS applications thereafter.
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: March 24, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): This program is described in the
Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.173 (NIDCD), 93.865
and 93.929 (NICHD), 93.853 (NINDS), 93.279 (NIDA), 93.866 (NIA), 93.286 (NIBIB)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This Program Announcement replaces PA-02-003.
The purpose of this Program Announcement (PA) is to encourage submission of new
research project grant (R01) and exploratory/developmental grant (R21) applications
to research and develop innovative technologies, methodologies, or instrumentation
for basic or clinical studies of the brain or behavior in human or non-human
animals. Also solicited are applications for support to research, develop, and
significantly enhance existing technologies that are important to understanding the
brain or behavior.
RESEARCH OBJECTIVES
In biomedicine, new tools and approaches often make possible quantum advances in
research on health and disease, and sometimes shift the manner in which such
research is undertaken, and results interpreted. Conversely, the complexity of
living systems represent interesting challenges to researchers, providing ample
opportunity for testing and expanding the limits of their science and technology.
The brain, and its product, behavior, represent one of the most complex systems in
biomedicine. Despite this, brain and behavioral sciences are rapidly advancing,
with important discoveries coming to light almost daily. These discoveries will
improve understanding of healthy brain function and offer promise to the millions
suffering from brain disorders of all types.
This PA seeks to enable neuroscience and behavioral research by soliciting research
and development of novel tools and approaches for the study of the development,
structure, and function of the brain. Such tools could include those used for
clinical assessment, diagnosis, and treatment of brain disorders. Significant
enhancements of existing technologies are also solicited. Research solicited under
this program announcement is not limited to any particular type of technology,
level of analysis, or approach. Multidisciplinary teams of researchers are
encouraged to apply.
Technologies appropriate for study, development and enhancement under this PA
include hardware, software, and wetware (and combinations of thereof) that would be
used to study the brain or behavior in basic or clinical research. The research
topics identified here represent examples of technologies that are appropriate for
this solicitation. These examples are not a complete list of the technologies
sought; they are intended only as a guide for determining the appropriateness of a
research topic.
Summary
This PA is expected to advance understanding of the nervous system and its product,
behavior, through support of research, development, and enhancement of a wide range
of technologies. Examples of hardware, software, and wetware that would be
considered appropriate under this PA for research, development and enhancement
include, but are not limited to:
o Microfluidic systems for in-vivo spatial and temporal controlled delivery of
neurotransmitters and other biomolecules
o Proteome analysis arrays, proteome data storage and analysis of proteome data
from the nervous system
o Genetic approaches to study structure or function of neural circuits in animal
models
o Biosensors that would be selectively activated by neurochemicals, such as
particular neurotransmitters or pharmacological compounds
o Delivery systems for exogenous agents such as drugs, gene transfer vectors, and
cells
o Non-invasive methods for in-vivo tracking of implanted cells
o Tools for real-time analysis of neurophysiological events
o Tools for data mining for genetic discovery and functional insights into
genomics and proteomics of the nervous system
o Nanocrystals or quantum dots covalently bonded to neural receptor ligands
o Probes of brain gene expression that can be imaged non-invasively (e.g., with
magnetic resonance or near infrared optical imaging)
o Genetic approaches to manipulate or monitor synaptic activity
o Microelectromechanical system (MEMS) devices used for monitoring neuron function
in slice and culture preparations
o Amplifiers that are small and light enough to be worn by mice for recording
neural activity from many neurons
o Tools, technologies and algorithms for neuroprosthesis development
o Tools to enhance visualization of specific brain markers
o New methods to study neural connectivity in living or post mortem brain,
especially human brain
o Improved electrodes, microcomputer interfaces, and microcircuitry for chronic
implantation, monitoring of neural activity, and promoting efferent function
o Dynamic monitors of intracranial pressure and cerebral spinal fluid composition
(particularly important in following disease progression or recovery from brain
injury)
o Devices for non-invasive diagnosis and precise identification of pathogens
involved in central and peripheral neural infectious diseases
o Tools for relatively non-invasive ways to assess damage and monitor function in
regions of injured or diseased brain tissue
o Non-invasive optical imaging instruments
o Technologies for detection, intervention, and prevention of acute, adverse
neurological events
o Tools for early-warning detection of imminent seizure activity; application of
targeted treatment to abort seizures
o Technologies to facilitate high-throughput analysis of behavior
o Tools for therapeutic electrical stimulation for rehabilitation following
stroke, trauma or other events or disorders that disrupt normal function of the
nervous system
o Telemetry devices small and light enough to be worn by mice for transmitting
data (e.g., electrophysiological data) during behavior
o Software to translate neuroimaging data from one data format into another
o Algorithms that use shape analysis approaches to understand human neuroimaging
data
o Computational approaches to analyzing video data (like those used in behavioral
research)
o Computational approaches and improved paradigms for analysis of kinematic data
It is stressed that the examples given above are not meant to be exhaustive, they
are merely given to suggest the kinds of projects that would be appropriate.
MECHANISM(S) OF SUPPORT
This PA will use the NIH Research Project Grant (R01) and Exploratory/Developmental
Grant (R21) award mechanisms. As an applicant, you will be solely responsible for
planning, directing, and executing the proposed project.
Information on the Exploratory/Developmental Grant (R21) is available at:
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.
This PA uses just-in-time concepts. It also uses the modular as well as the non-
modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you
are submitting an application with direct costs in each year of $250,000 or less,
use the modular format. Otherwise follow the instructions for non-modular research
grant applications. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply for
NIH programs.
SPECIAL REQUIREMENTS
Applications submitted in response to this program announcement may be design-,
problem-, need-, or hypothesis-driven. Thus, the application should state the
hypotheses, designs, problems and/or needs that will drive the proposed research.
As plans for technology research, development, and enhancement are augmented by
specific feasibility tests of the technology and/or milestones, these should be
presented in the Research Design and Methods section. Finally, applications should
include a plan for making available to the research community the technologies
developed or enhanced by grants funded under this PA; this should be described in
the Research Design and Methods section of the application. NIH policy requires
that investigators make unique research resources produced with DHHS funding
available for research purposes to qualified individuals within the scientific
community (NIH Grants Policy Statement - March 2001, Part II Subpart A,
Availability of Research Results: Publications, Intellectual Property Rights, and
Sharing Biomedical Research Resources, page 120-122, "Sharing Biomedical Research
Resources," available at
http://grants.nih.gov/archive/grants/policy/nihgps_2001/nihgps_2001.pdf; see also PHS
policy relating to the distribution of unique research resources produced with PHS
funding at http://grants.nih.gov/grants/guide/notice-files/not96-184.html. The
intent of this policy, however, is not to discourage, impede, or prohibit the
organization that develops unique research resources or intellectual property from
commercializing the products.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two areas:
scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Michael Huerta, Ph.D.
Division of Basic and Clinical Neuroscience Research
National Institute of Mental Health
6001 Executive Blvd. Room 7202, MSC 9645
Bethesda, MD 20892-9645
Rockville, MD 20852 (for express or courier service)
Telephone: (301) 443-3563
FAX: (301) 443-1731
Email: mhuert1@mail.nih.gov
Roger Miller, Ph.D.
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: millerr@nidcd.nih.gov
Ralph Nitkin, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4206
FAX: (301) 402-0832
Email: rn21e@nih.gov
Daofen Chen, Ph.D.
Program Director, Channels/Synapses/Circuits
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2131, MSC 9523
Bethesda, MD 20892-9523
Telephone: (301) 496-1917
FAX: (301) 402-1501
Email: dc342b@nih.gov
Thomas G. Aigner, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 443-6975
FAX: (301) 594-6043
Email: ta17r@nih.gov
Bradley C. Wise, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: wiseb@nia.nih.gov
Grace C.Y. Peng, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200, MSC 5469
Bethesda, MD 20892
Telephone: (301) 496-9178
FAX: (301) 480-4973
Email: penggr@mail.nih.gov
Philip F. Smith, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 689, MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-8816
FAX: (301)480-3503
Email: ps56z@nih.gov
o Direct your questions about financial or grants management matters to:
Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: crobinso@mail.nih.gov
Ms. Sara Stone
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC-7180
Bethesda, MD 20892
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: stones@nidcd.nih.gov
Annette Hanopole
Grants Management Branch
National Institute for Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5002
Email: ah23k@NIH.GOV
Ms. Karen Dunlap
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290, MSC 9537
Bethesda, MD 20892-9537
Telephone: (301) 496-7359
FAX: (301) 402-0219
Email: kd177c@nih.gov
Gary Fleming, J.D.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@nih.gov
Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippl@nia.nih.gov
Mr. Nick Mitrano
Grants Management Branch
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892
Telephone: (301) 451-4782
FAX: (301) 480-4974
Email: mitranni@mail.nih.gov
Kathleen Shino
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room, 708 MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8869
FAX: (301) 480-3504
Email: ks48e@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. The DUNS number can be
obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of
the face page of the PHS 398 form. The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:
GrantsInfo@nih.gov.
The title and number of this PA must be typed on line 2 of the face page of the
application.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which are
available at http://grants.nih.gov/grants/dates.htm. Application deadlines are
also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up
to $250,000 per year in direct costs must be submitted in a modular grant format.
The modular grant format simplifies the preparation of the budget in these
applications by limiting the level of budgetary detail. Applicants request direct
costs in $25,000 modules. Section C of the research grant application instructions
for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular grants is
available at http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must include
a cover letter identifying the NIH staff member within one of NIH institutes or
centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application,
i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for
consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member and IC
who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised version of
these grant application types. Additional information on this policy is available
in the NIH Guide for Grants and Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the checklist, and five signed photocopies in one package
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates
described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA that is essentially the same
as one currently pending initial review unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially the same
as one already reviewed. This does not preclude the submission of a substantial
revision of an application already reviewed, but such application must include an
Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of established PHS
referral guidelines. Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under review, will
be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council or
board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of biological
systems, improve the control of disease, and enhance health. In the written
comments, reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review group will
address and consider each of these criteria in assigning the application's overall
score, weighting them as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of the
application are achieved, how will scientific knowledge be advanced? What will be
the effect of these studies on the concepts or methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are
the aims original and innovative? Does the project challenge existing paradigms or
develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience level of the
principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items
will be considered in the determination of scientific merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects
and protections from research risk relating to their participation in the proposed
research will be assessed. (See criteria included in the section on Federal
Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and subgroups),
and children as appropriate for the scientific goals of the research will be
assessed. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be
used in the project, the five items described under Section f of the PHS 398
research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the
proposed research are expected to include a data sharing plan in their application.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not factor
the proposed data sharing plan into the determination of scientific merit or
priority score.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds with
all other recommended applications. The following will be considered in making
funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the importance
of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all
types of clinical trials, including physiologic, toxicity, and dose-finding studies
(phase I); efficacy studies (phase II), efficacy, effectiveness and comparative
trials (phase III). The establishment of data and safety monitoring boards (DSMBs)
is required for multi-site clinical trials involving interventions that entail
potential risk to the participants. (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in direct
costs in any single year are expected to include a plan for data sharing or state
why this is not possible. http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and Federal laws
and regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the scientific
merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the "NIH Guidelines for
Inclusion of Women and Minorities as Subjects in Clinical Research - Amended,
October, 2001," published in the NIH Guide for Grants and Contracts on October 9,
2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The
amended policy incorporates: the use of an NIH definition of clinical research;
updated racial and ethnic categories in compliance with the new OMB standards;
clarification of language governing NIH-defined Phase III clinical trials
consistent with the new PHS Form 398; and updated roles and responsibilities of NIH
staff and the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or proposals and/or
protocols must provide a description of plans to conduct analyses, as appropriate,
to address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic
group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21) must
be included in all human subjects research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them. This policy
applies to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.
All investigators proposing research involving human subjects should read the "NIH
Policy and Guidelines" on the inclusion of children as participants in research
involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects. You
will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It
is the responsibility of the applicant to provide, in the project description and
elsewhere in the application as appropriate, the official NIH identifier(s)for the
hESC line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office
of Management and Budget (OMB) Circular A-110 has been revised to provide public
access to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported in
whole or in part with Federal funds and (2) cited publicly and officially by a
Federal agency in support of an action that has the force and effect of law (i.e.,
a regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description of
the archiving plan in the study design and include information about this in the
budget justification section of the application. In addition, applicants should
think about how to structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health Information", the
"Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that
governs the protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR). Those who
must comply with the Privacy Rule (classified under the Rule as "covered entities")
must do so by April 14, 2003 (with the exception of small health plans which have
an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with
the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information on the impact of
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be found
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be
used to provide information necessary to the review because reviewers are under no
obligation to view the Internet sites. Furthermore, we caution reviewers that
their anonymity may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This PA is related to one or
more of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education, library,
day care, health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.